Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly *
研究概览
简要总结
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.
详细描述
Randomised, placebo controlled, double blind, cross-over design
Primary study outcome is:
Performance in a verbal memory task.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment.
Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •normotensive (BP between 90/60mmHg and 140/90mmHg)
- •BMI between 19 and 29 kg/m2
- •aged between 18 and 40 years
- •experiencing chronic stress for at least 1 month (TICS sum score in subscale "overextension at work" >= 55)
- •native or fluent German-speaking
- •able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
- •willing to donate saliva sample for DNA-analysis
- •female: willing to perform a pregnancy test at the beginning of both medication phase and at the follow-up visit.
排除标准
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs
- •acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress
- •cognitive impairment as detected by DemTect
- •concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
- •women who are pregnant or breast feeding
- •intention to become pregnant during the course of the study
- •lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- •active peptic ulcer or antecedents or complicated peptic ulcer or history of peptic ulcer. Any other active pathological bleeding
- •history of coagulation abnormality
- •thyroid problems
- •laboratory exclusion criteria: clinically significant values of blood count (incl. platelets), coagulation status or blood chemistry outside reference range of laboratory
- •pathological ECG
- •known or suspected non-compliance, drug or alcohol abuse
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •participation in another study with investigational drug within the 30 days preceding -
研究组 & 干预措施
Verum/Placebo
This group will start with triflusal and after washout will receive placebo.
干预措施: Triflusal (Drug)
Verum/Placebo
This group will start with triflusal and after washout will receive placebo.
干预措施: Placebo (Drug)
Placebo/Verum
This group will start with placebo and will receive triflusal after washout.
干预措施: Triflusal (Drug)
Placebo/Verum
This group will start with placebo and will receive triflusal after washout.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly *
时间窗: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
次要结局
- Change in performance in working memory task between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
- Change in performance in episodic memory task between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
- Change in performance in a memory game between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
- Change in subjective memory impairment between placebo and verum(20 min before last medication of each placebo and verum)
- Mood state changes between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
- Changes in depressive symptoms between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
- Changes in anxiety symptoms between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.)
研究者
Prof. Dominique de Quervain, MD
Director
University of Basel